Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: budesonide/formoterol; Drug: budesonide and placebo

• Registration Number: NCT00652392
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-06
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Diagnosis of asthma and baseline lung function tests as determined by the protocol
• Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

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Exclusion Criteria

• Severe asthma
• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	budesonide/formoterol	-
2	budesonide and placebo	-

Primary Outcome Measures

Name	Time	Method
Change in evening PEF	Daily throughout the 12 week treatment period

Secondary Outcome Measures

Name	Time	Method
Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes	Daily throughout the 12 week treatment period
Health-related quality of life	4 assessments within 12 week treatment period
Routine safety assessments	4 assessments within 12 week treatment period